Open-Label Trial Comparing Oxycodone Medications (OUTCOMES)
The investigators hypothesize that subjects will have greater pain relief when taking IR-oxycodone compared with ER-oxycodone for several reasons. The ability to take a varying amount of medication at six different points over the course of a day will allow patients to take as much (or as little) medication as they need to control their pain. In addition, the ability to vary the medication doses in this way will give them a greater sense of control, which will also contribute to greater pain relief. Similarly, the investigators predict that patients will show greater benefits with IR-oxycodone on the measures of physical and emotional functioning. Because there is relatively little data on sleep apnea in chronic pain patients (Webster et al., 2008), these assessments are exploratory and not hypothesis-based. Finally, although it is typically thought that the abuse liability of IR-opioid medications is greater than for ER-medications, the data on which this belief are based have not involved systematic studies of patients with chronic pain; the assessments of abuse liability will therefore also be exploratory.
Drug: Extended Release Oxycodone
Drug: Immediate Release Oxycodone
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label Trial Comparing Oxycodone Medications for Effectiveness and Satisfaction (OUTCOMES)|
- Numerical Pain Rating Scale (NRS) [ Time Frame: Daily ] [ Designated as safety issue: No ]The primary outcome measure for this clinical trial will be pain relief documented in the subjects' daily pain diaries. Specifically, the average of the daily pain ratings recorded by subjects during the final weeks of the two treatment periods will be compared. The treatment comparison of interest is IR-oxycodone vs. ER-oxycodone, which will be tested at the p < 0.05 level using a two-tailed test.
- Brief Pain Inventory [ Time Frame: Visits 2-6 ] [ Designated as safety issue: No ]Will be administered to assess the extent to which chronic pain interferes with sleep and physical and emotional functioning.
- Hospital Anxiety and Depression Scale [ Time Frame: Visits 2-6 ] [ Designated as safety issue: No ]The HADS will be administered to assess anxiety and depression.
- Short Form Health Survey (SF-36) [ Time Frame: Visits 2, 4 and 6 ] [ Designated as safety issue: No ]It is a 36-item questionnaire designed to measure general health related quality of life.
- Patient Global Impression of Change [ Time Frame: Visits 4 and 6 the end of each of the two treatment periods ] [ Designated as safety issue: No ]This rating on a 7-point scale measures a patients overall assessment of change since starting a given treatment. This measure provides a subjects global assessment of change, presumably including change in pain, side effects, change in functional status, convenience of therapy, subject preference and values and overall satisfaction with the intervention.
|Study Start Date:||March 2010|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: ER Oxycodone vs IR Oxycodone
Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.
IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours
Drug: Extended Release Oxycodone
40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours
Other Name: Medication comparisonDrug: Immediate Release Oxycodone
IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours
Other Name: Medication comparison
This study is a single-center, randomized, open-label, 13-week, 2-period crossover clinical trial. Subjects will complete each of the following (unless they withdraw from the trial): (1) a one-week baseline period during which the subject completes pain diaries and remains on stable dosages of their existing pain medications; (2) immediate-release (IR) oxycodone 5 mg 3-4 pills every four hours; (3) extended-release (ER) oxycodone 40 mg 1 pill every 12 hours and IR-oxycodone 5 mg 1-2 pills every six hours. Subjects will be randomized to one of two treatment sequences (ER-oxycodone first then IR-oxycodone or vice verse). It is expected that this trial will take approximately 2 years to complete.
Crossover periods. Each of the two treatment periods will be 6 weeks in duration, which will allow ample time to assess pain relief, adverse effects, treatment satisfaction, and impact of treatment on health-related quality of life. There will be no need for a titration period at the beginning of either period or for a washout period before the second period because oxycodone at the same dosages will be administered in both periods. At each visit, subjects will be given sufficient medication to sustain them until at least the following visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162304
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Joel L Kent, MD||University of Rochester|